Good Clinical Practice (GCP), Good Clinical laboratory practice (GCLP) and Protocol familiarization training - Ethiopia

The PREGART Clinical trial project conducted its kick-off meeting in September 2019. However, the trial participant recruitment initiated after two years of delay due to the impact of Covid-19 and lack of clinical trial insurance provider for timely ethical approval. As a catch-up plan, the project office in Ethiopia has identified additional 9 study hospitals that fulfilled the eligibility criteria.

A two days training on protocol popularization, Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) was given from September 3-4, 2022 for the newly added trial site staffs to equip them with the necessary knowledge and skills of clinical trial implementation according to the international standards.

Forty-five trial site staffs, with different professional categories (Obstetrician/ gynaecologist, PMTCT nurses, Laboratory technologist, Pharmacist) and who will be responsible for the site trial implementation participated in the two days training.

Figure 1: Logo of the consortium
Picture 1: Participants attending presentations
Picture 2: Partial view of Trainees

Stakeholders engagement meeting at Adama, Ethiopia

The Pregart Clinical trial in Ethiopia has been enrolling participants since May 2021. The project has enrolled 16% of its target as of June 2022. Recruitment of participants was supposed to start January 2020, but it was delayed due to Covid-19 pandemic and ethical approval process. As part of the mitigation plan to enhance the recruitment process, Hawassa University organized a one-day stakeholders engagement meeting on July 30, 2022 at Adama City, Hillside Hotel in Oromia region.

The meeting aimed at updating the stakeholders the progress of Pregart clinical trial progress (performance in terms of timeline and challenges).The meeting was held to enhance support and engagement of the stakeholders through discussions on the pertinent issues and challenges faced in the course of implementation of the trial that will facilitates the recruitment process to achieve the project objectives within the remaining timeline. The participants were identified based on their direct or indirect roles in creating awareness facilitating communications about the project across the existing structures of health delivery system. These include participants from the Ministry of Health, Regional Health Bureau of Oromia; Southern Nations, Nationalities and Peoples Region; Sidama Region; and Addis Ababa City Council.

Moreover, representatives from the National Ethics Committee, Ethiopian Public Health Institute, Addis Ababa Regional Laboratory, and prevention of mother to child transmission (PMTCT) coordinators took part in the meeting. Thirty-five participants attended the meeting. The trial investigators presented the progress of the trial, success and major challenges and finally all the participants discussed the identified challenges and recommended different interventions to be taken at the different level of healthcare system.

Picture 1: Participants attending presentations
Picture 2: Panellists leading the discussion (Dr. Aregash, Prof. Yifru, Dr. Abel-Left to right)

 

Picture 3: Partial view of meeting attendants

 


Pregart clinical trial situation in Uganda

The recruitment of trial participants on the Ugandan arm of the Pregart study kicked off on the 28th of September 2021 and it has been running to-date for approximately 17 weeks.

So far, the team has managed to enroll about 40 participants, of these, 3 have delivered, and all mothers and babies are faring well.

An unfortunate encumbrance in picking up recruitment numbers occurred mostly from the current global Covid-19 pandemic and the related setbacks. Solutions to mitigate this situation have been put in place for a hopefully better outcome. Aside from these overt challenges, the trial thus far is progressing steadily with a hope that it shall pick up to enable the team meet project’s end goals.


Update on Pregart clinical trial participant recruitment as of 13th October 2021

The Ugandan team started participant recruitment on 21st September 2021, with a total of 8 participants recruited to date. Prior to recruitment we had retraining of the Trial site staff on the Protocol, data collection tools and SOPs, to enable smooth understanding and running of participant recruitment.

Retraining of on PREGART Protocol, SOPs and Data collection tools at MildMay Hospital

 

 

Screening and Consenting
Participant being reviewed by the clinician
Lab personnel prepping to take off sample from a trial participant and sample that was taken off


Hawassa University Pregart clinical trial project PhD candidates presented their thesis concept note

One of the Pregart clinical trial project deliverable is clinical trial capacity building in Africa.  Accordingly, one of the project consortium institutions, Karolinska Institute (KI) in Sweden will enroll 4 PhD and 2 -Post doc students from Hawassa University and Makerere University. Two of the PhD candidates from Hawassa university; Mr. Siraj Hussein from department of Medical Laboratory Science and Dr. Abel Gedefaw from School of Medicine presented their thesis concept note to their advisors on September 21/2021 at Hawassa University project office. Professor Eleni Aklilu from KI and Professor Eyasu Mekonnen from Addis Ababa University attended the presentation onsite at the office while Professor Stefano Vella from KI attended online using zoom. The PhD candidate’s registration process at KI will be completed in the coming two months.

One of the PhD candidates (Mr. Siraj Hussien) presenting his thesis concept note. Professor Eleni Aklilu and Professor Eyasu Mekonnen attending the presentation at Hawassa University Pregart project office

 

Professor Stefano Vella from KI attending the PhD candidate thesis concept note

Hawassa University President welcome Pregart clinical trial investigators

Hawassa University president, Dr. Ayano Beraso, warmly welcome Pregart clinical trial investigators on September 20/2021 at the president office. The visiting investigators, Professor Eleni Aklilu from Karolinska institute and Professor Eyasu Mekonnen from Addis Ababa university, has briefed the president on the trial implementation status progress and the recent activity plan. The President reassured to the team that he will continue following up of the project implementation in order to achieve the project deliverables.

Pregart clinical trial investigators with Hawassa University president during visit at the president office.

 

Professor Eleni with Dr. Ayano ( President) during president visit at his office.

 

Hawassa University President welcome Pregart investigators at President office.

Pregart project investigators conducted trial hospital site visit

Professor Eleni Aklilu from Karolinska institute, Professor Eyasu Mekonnen from Addis Ababa university with Hawassa University trial lead team members, conducted site visit to one of the trial site hospitals, Hawassa University Comprehensive Specialized hospital on September 20/2021. The investigators evaluated the quality of data collection, GCP compliant status during trial implementation and provide positive feedback to the team for future strengthening of the trial.

Professor Eleni and Professor Eyasu evaluating participant folder during Hawassa University comprehensive Specialized hospital site visit
Hawassa University comprehensive Specialized hospital trial site staffs briefing on the implementation process to the visiting investigators at the trial site office.

Pregart clinical trial Ethiopia trial lead team conducted project implementation status review meeting

A two-day review meeting, September 21-22/2021, was conducted on the Ethiopia Pregart clinical trial implementation status at the University project office.  Most of the Ethiopia trial lead team (Dr. Birkneh Tilahin, Professor Eleni Aklilu, Professor Eyasu Mekoknnen , Dr. Abel Gedefaw , Dr. Dejene Hailu , Mr Siraj , Sintayehu Hailu , Negede Yohannes , Biruk kebede and others ) attended the meeting.  The trial current implementation status, challenges and anticipated risks presented for discussion by three presentations. After in depth discussions, the trial lead team decided to initiate the trial recruitment in all the trial sites, fasten the recruitment process in the already initiated trial sites, finalize the PhD candidate’s thesis concept note, request protocol amendment to respective ethical and regulatory institutions to avoid protocol related bottlenecks of participant recruitment.

Trial lead team project implementation status review workshop meeting at the project office

 

Ethiopia Pregart project trial lead team review meeting workshop at project office

 

Trial lead team review meeting workshop at Hawassa University project office

Pregart clinical trial project in Ethiopia has started participant recruitment in the third trial site

After the long impact of Covid-19 pandemic to the clinical trial implementation timeline, the Hawassa University trial lead team conducted site initiation visit from September 1-5/ 2021 and started participant recruitment per protocol at the third trial site in Bahirdar Felegehiwot Comprehensive Specialized hospital.

Site initiation meeting with the site research staffs at Bahirdar Felegehiwot Comprehensive Specialized hospital.

 

Research staffs training at Bahirdar Felegehiwot Comprehensive Specialized hospital during site initiation

 

The first recruited participant sample analysis at Bahirdar Felegehiwot Comprehensive Specialized hospital

Pregart clinical trial project in Ethiopia has started participant recruitment in the second trial site

After the long impact of Covid-19 pandemic to the clinical trial implementation timeline, the Hawassa University trial lead team conducted site initiation visit from August 26-30/ 2021 and started participant recruitment per protocol at the second trial site in Gondor Comprehensive Specialized hospital.

Site initiation meeting with the site research staffs at Gondor Comprehensive Specialized hospital